Regulatory authorities reiterated the "anti drug restriction order" and the "ice and fire dual nature" of Chinese and Western pharmaceutical materials

Source: China Securities Journal February 3, 2015 Ma Xiaowei, deputy director of the national health and Family Planning Commission, said at the National Conference on rational drug use held on May, that we should focus on the management of antimicrobial drugs, promote the management of rational drug use, focus on the extension of antimicrobial drug management to grass-roots and private medical institutions, realize the full coverage of the medical service industry, and promote the rational use of antimicrobial drugs Previously, the regulatory authorities have repeatedly ordered, this time the regulatory authorities will again rational drug use management as a key work Industry analysis, antimicrobial management will usher in a high-pressure situation After the "anti restriction order" came out of the Jianghu again, the lethality of antibiotic and other chemical medicine enterprises is self-evident, but it is a great opportunity for Chinese patent medicine injection enterprises Ma Xiaowei said that the national health and Family Planning Commission, the local health and family planning administrative departments at all levels, and all kinds of medical institutions at all levels have taken a series of measures to promote the rational use of antibiotics and made great achievements However, the current situation of rational use of drugs is still grim, the cost of drug use still keeps a high growth rate, the level of rational use of drugs needs to be further improved, and the normalized regulatory mechanism has not been fully formed, especially the bacterial resistance caused by the unreasonable use of antibacterial drugs, which makes the medical quality and safety face great challenges According to Ma Xiaowei, the next step is to focus on the extension of antimicrobial drug management to grass-roots and private medical institutions to achieve full coverage of the medical service industry; establish a long-term management mechanism, strictly grasp the implementation of various systems and indicators of antimicrobial drug management; establish a multi-disciplinary participation, multi sector linkage guidance and management network for antimicrobial drug application, and comprehensively improve the management of antimicrobial drug application Management level; strictly implement the responsibility system of rational drug use management, strengthen supervision and inspection; establish a joint mechanism with the relevant departments of antibacterial drug management to form a joint force On January 28, the national health and Family Planning Commission issued the notice on printing and distributing the action plan for further improvement of medical services, which stipulates that the use of prescription negative list management, prescription comment and other forms to control the unreasonable use of antibacterial drugs By the end of 2017, the utilization rate of antibacterial drugs for inpatients in the general hospital will not exceed 60%, and the intensity of antibacterial drug use will be controlled below 40 DDDs per 100 person days Other types of hospitals have reached the special treatment index for clinical application of antibacterial drugs To standardize the clinical application of hormone drugs, anti-tumor drugs and auxiliary drugs, strengthen the clinical use intervention, promote individualized drug use, and reduce the drug damage of patients Antibiotics are stronger than tigers As early as may 2012, the former Ministry of health has promulgated the administrative measures for clinical application of antibacterial drugs (hereinafter referred to as the administrative measures), which was officially implemented on August 1, 2012 Since 2011, the national special campaign on clinical application of antibacterial drugs has been launched, and the health department has made another great effort to strengthen the management of antibacterial drugs This policy is interpreted as "restraining order" by the industry Xiao Yonghong, member of the Expert Committee on rational use of drugs of the health and Family Planning Commission and deputy leader of the antibacterial group, said that "anti drug restriction order" is a simplified understanding The original intention of the regulatory authorities is not to restrict the use of antibacterial drugs, but to promote their rational use The strict management of antibiotics can reduce the bacterial drug resistance caused by the unreasonable use of antibiotics "Unlike many remission and improvement drugs, antibacterial drugs are the only drugs that can effectively cure diseases in human history However, bacterial resistance will destroy this great scientific discovery." The industry is facing a new round of strict licensing restrictions storm The profits of pharmaceutical enterprises with antibiotics as the main industry will be tightened, and the industry is also facing a new round of licensing Before and after 2005, the rapid development of drug resistance has appeared in China, and the trend of bacterial drug resistance is still in the high platform stage In order to improve the drug resistance of bacteria, the regulatory authorities have launched several rounds of "severe beating" since 2011, one of the obvious changes is the decline of clinical use of antibiotics According to statistics, in 2013, the antibacterial drugs purchased by sample hospitals ranked first for many years and were replaced by anti-tumor drugs At present, there are too many low-level repeated antimicrobial products in China For example, the penicillin market has gathered five major manufacturers of Huabei pharmaceutical, Harbin Pharmaceutical Co., Ltd., Lukang Pharmaceutical, Shijiazhuang Pharmaceutical and Huaxing Pharmaceutical to compete for shares, and the number of other small penicillin manufacturers is even larger "Anti restriction order" is very painful for pharmaceutical companies From 2011 to the first three quarters of 2014, the net profit of Lukang Pharmaceutical, one of the four traditional antibiotics, increased by - 88%, - 991.45%, 108% and - 53.75%, respectively Among them, in 2013, the company received a large amount of government subsidies to improve its performance Yu Mingde, President of China Pharmaceutical Enterprise Management Association, said, "under the situation of strict supervision on the use of antibiotics, small and medium-sized pharmaceutical enterprises are relatively easy to transform For large traditional antibiotic enterprises with decades of production history, the transformation will be more difficult The industry will go through a reshuffle " Xiao Yonghong said that even if the amount of antibacterial drugs rebounded after the rectification, enterprises should not have illusions and take this opportunity to adjust the transformation From the current market situation, the enterprises that have no R & D ability are the main ones that have been fatally hit Brand drugs and innovative drugs have not lost their market due to the strict management of antibacterial drugs Guo Fanli, a consultant of CIC, said that in the future, pharmaceutical enterprises should deal with or transform from three aspects, limit the variety and quantity of drug production, improve the standardized production of antibacterial drugs, build a platform for research and development of antibacterial drugs, and actively raise funds to ensure sufficient cash flow Compared with many domestic pharmaceutical enterprises mainly engaged in antibiotics, the opportunities of traditional Chinese medicine enterprises are looming The market of traditional Chinese medicine injection with antibacterial effect is sunny According to Gan Rongfu, a senior industry researcher of Sinopharm holding, the clinical use of chemical antibiotics is tightened, while traditional Chinese medicine antibiotics are not limited; traditional Chinese medicine antibiotics are increasingly favored by patients due to their small side effects and no drug resistance Yiling pharmaceutical, xinlitai and other traditional Chinese antibacterial drugs will have a great opportunity to develop Industry insiders told reporters that "anti restriction" may significantly improve the use of cough, expectorant, antiasthmatic and heat clearing and detoxification Chinese medicine, especially for modern Chinese medicine enterprises with new dosage forms (traditional Chinese medicine injection) "Take the cold and fever as an example Now doctors prescribe Chinese medicine with the function of clearing away heat and detoxifying to many children with fever and cough, especially the cold caused by virus Chinese patent medicine can resist virus, but its side effect is still small " According to the above sources, at present, it is generally believed that traditional Chinese medicine has a good therapeutic effect on a variety of infectious diseases The auxiliary application of traditional Chinese medicine such as clearing away heat, promoting dampness, promoting blood circulation and removing stasis, detoxification and so on can reduce the application dose of antibacterial drugs For children, the elderly or people who can't use antibacterial drugs due to physical reasons, as well as patients who are resistant to antimicrobial drugs, traditional Chinese medicine is a good choice 。 The data shows that traditional Chinese medicine injection has become the largest market share in the field of traditional Chinese medicine In the market share of cardio cerebrovascular and anti-tumor Chinese patent medicine, the top 10 products account for 7 seats in total There are more than 50 kinds of commonly used traditional Chinese medicine injections, the overall market size is about 25 billion-30 billion yuan, and the compound growth rate in the past five years is about 21%, which is significantly higher than the income growth rate of 18.23% of the whole drug market.